Panels › Gastroenterology, Urology › Product code FDT · Class 2
Duodenoscope And Accessories, Flexible/Rigid
Regulation 876.1500
2510(k)s in 12 months (35 all time)
8recalls in 12 months (38 all time)
37recalls that name a 510(k)
Top companies in FDT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2026 | Olympus Corporation of the Americas Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the in Open, Classified |
FDT | K220587 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 18-20mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 15-18mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 12-15mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 10-12mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 8-10mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 6-8mm 240cm Open, Classified |
FDT | K110833 |
| Nov 21, 2025 | Olympus Corporation of the Americas Brand Name: EVIS EXERA III Duodenovideoscope
Product Name: Olympus TJF-Q190V
Model/Catalog Number: TJF-Q190V
Product Description: This instrument is intended to be used with an Olympus video system ce Open, Classified |
FDT | K251867 |
| Feb 9, 2024 | Olympus Corporation of the Americas Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V-
designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around t Open, Classified |
FDT | K220587 |
| Nov 21, 2023 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0. Open, Classified |
FDT | K193202 |
| Nov 21, 2023 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. Open, Classified |
FDT | K193202 |
| Aug 28, 2023 | Olympus Corporation of the Americas EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V Open, Classified |
FDT | K193182 K202661 +1 |
| May 19, 2023 | Olympus Corporation of the Americas Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100 Open, Classified |
FDT | K193182 |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope (Box 2)
UPN: M0054242CE1
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf Open, Classified |
FDT | K193202 |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope (Box 1)
UPN:M0054242CE0
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perfor Open, Classified |
FDT | K193202 |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single- Use Duodenoscope (Box 2)
UPN: M00542421
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf Open, Classified |
FDT | K193202 |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single- Use Duodenoscope (Box 1)
UPN: M00542420
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf Open, Classified |
FDT | K193202 |
| Dec 10, 2021 | Olympus Corporation of the Americas EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V
Model Number: TJF-Q180V Open, Classified |
FDT | K143153 |
| Apr 21, 2021 | Pentax of America Inc Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic Terminated |
FDT | K192245 K210710 |
| Mar 16, 2021 | Boston Scientific Corporation EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 Terminated |
FDT | None listed |
| Jan 28, 2021 | Olympus Corporation of the Americas Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps Terminated |
FDT | K193182 |
| Feb 20, 2018 | Pentax of America Inc Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic ac Terminated |
FDT | K092710 K161222 |
| Jul 21, 2017 | Fujifilm Medical Systems U.S.A., Inc. FUJINON ED-530XT.
This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, st Terminated |
FDT | K152257 |
| Jan 17, 2017 | Pentax of America Inc Video Duodenoscope
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includ Terminated |
FDT | K092710 K963056 |
| Jul 23, 2016 | Pentax Medical Company Duodenoscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; an Terminated |
FDT | K963056 |
| Mar 15, 2016 | Olympus Corporation of the Americas EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF
used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment f Terminated |
FDT | K024033 |
| Feb 22, 2016 | Pentax Medical Company Video Duodenoscope Terminated |
FDT | K092770 |
| Feb 4, 2016 | Olympus Corporation of the Americas Olympus TJF-Q180V flexible gastrointestinal Duodenoscope
Product Usage:
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monito Terminated |
FDT | K080403 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-450XL5
Operation Manual: Cleaning, Disinfection and Storage Terminated |
FDT | K042076 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-450XT5
Operation Manual: Cleaning, Disinfection and Storage Terminated |
FDT | K042076 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-250XT5
Operations Manual: Cleaning Disinfection and Storage Terminated |
FDT | K944759 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-250XL5 Operations Manual: Cleaning, Disinfection Terminated |
FDT | K944759 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope; ED-530XT Operation Manual
'Operation and Preparation' and 'Cleaning, Disinfection and Storage' Terminated |
FDT | K042076 |
| Sep 22, 2015 | Olympus America Inc. EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy Terminated |
FDT | K080403 |
| Sep 17, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. Terminated |
FDT | K042076 K944620 |
| Aug 31, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. Terminated |
FDT | K944759 |
| Mar 9, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Endoscope
Models
ED-250XL5
ED-250XT5
ED-450XT5
ED-450XL5
Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, d Terminated |
FDT | K152257 |
| Mar 9, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Endoscope
Model ED-530XT
Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of Terminated |
FDT | K152257 |
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